Clinical trial · Interventional
Clinical Investigator-Initiated Trial (IIT) of PD-L1-Targeted Radionuclide Probes
NCT07848243CI-TRIAL-00126690recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
\[18F\]F-PDL1-3 molecular probe was used to detect the expression of PD-L1 in primary and metastatic tumors of patients with solid tumors. The heterogeneity of PD-L1 expression in the same lesion and different lesions was further evaluated, and the changes of PD-L1 expression in the course of the disease were observed. This method is helpful for the screening of patients with solid tumors with high PD-L1 expression, efficacy monitoring, and early warning of drug resistance and/or recurrence or metastasis, and ultimately achieve individualized targeted therapy of tumors
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Squamous Cell Cancer | Cervical Squamous Cell Carcinoma | ALIAS | 0.90 |
| Gastrointestinal Cancers | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Drug | — | UNRESOLVED |
| [18F]F-PDL1-3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]F-PDL1-3
- description
- All study participants will be assigned to this group (single-group study). Study participants will undergo \[18F\]F-PDL1-3 PET/CT scans. The injection dose was 1.52-2.72 MBq/kg. Whole-body imaging of the head and trunk will be performed using a United imaging EXPLORER whole-body PET/CT scanner at 1 h, 2 h, and 3 h post-injection after participants have rested quietly for 40 min or 1 h. The scan range was from the apex of the thigh to the upper third of the thigh. Participants requiring dynamic scanning underwent a 40-min serial scan after injection of \[18F\]F-PDL1-3.. PET/CT static imaging was performed at 3h after injection.
- interventionNames
- Drug: 18F-FDG
- Drug: [18F]F-PDL1-3
Primary outcomes (4)
- measure
- Safety - Tracer-related Adverse Events
- timeFrame
- From the start of radiotracer administration through 7 days after injection.
- description
- Number of participants with tracer-related adverse events.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>18 years old, ECOG score 0 or 1; 2. subjects with pathologically confirmed solid tumors (lung cancer, cervical cancer, melanoma, breast cancer, gastrointestinal tumor, etc.), recent recurrence or suspected recurrence of previous solid tumors; 3. There was at least one measurable target lesion according to RECIST1.1 criteria; 4. Predicted survival time ≥12 weeks; 5. Blood routine, liver and kidney function meet the following standards: see the study protocol for specific requirements; 6. Women must be using an effective contraceptive method (effective contraception means sterilization, intrauterine hormonal devices, condoms, contraceptives/pills, abstinence, or partner's removal of the vas deferentia) during the study and for 6 months after the study; Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period; 7. Subjects can fully understand and voluntarily participate in this experiment, and sign an informed consent. Compliance was good. Exclusion Criteria: 1. Severe abnormal liver and kidney function. 2. Pre-pregnancy, pregnant and lactating women. 3. Unable to lie flat for half an hour. 4. Refusal to be a clinical investigator. 5. Claustrophobia or other mental illness. 6. Known allergy to the investigational drug or its excipients in the study treatment; Other circumstances considered by the investigator to be inappropriate for trial participation.
References
Publications (0)
Data not yet available
No reference posted for this study.